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NCT00426764 · BASELINE

Baseline characteristics

A Trial of Romidepsin for Progressive or Relapsed Peripheral T-cell Lymphoma · Source last updated 2020-02-11

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms
  1. counts
    1. group Id
      BG000
      value
      131
    units
    Participants
groups
  1. description
    Participants received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Participants who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
    id
    BG000
    title
    Romidepsin
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.83
          value
          59.4
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          42
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          89
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          116
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      Other
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.2348
          value
          1.84
      denoms
      1. counts
        1. group Id
          BG000
          value
          128
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    participants with a Baseline measurement
    title
    Body Surface Area (BSA)
    unit Of Measure
    m^2
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          46
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          66
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      2
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      Missing
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      Unknown
    description
    The ECOG scale is as follows: Grade 0: Fully active, able to carry on all pre-disease activities without restriction; Grade 1: Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; Grade 2: Ambulatory and capable of all self-care but unable to work. Up and about more than 50% of waking hours; Grade 3: Capable of only limited self-care, confined to bed or chair \> 50% of waking hours; Grade 4: Completely disabled. Cannot carry on any self-care. Confined to bed or Chair.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group Performance Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          2.6654
          value
          2.268
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Duration of peripheral T-cell lymphoma (PTCL)
    unit Of Measure
    years
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          69
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      PTCL Unspecified (NOS)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          27
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      Angioimmunoblastic T-cell lymphoma (AITL)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          21
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      ALK-1 negative ALCL
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      Enteropathy-type T-cell lymphoma
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      Subcutaneous panniculitis-like T-cell lymphoma
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      ALK-1 positive ALCL
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      Cutaneous γδ T-cell lymphoma
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      Extranodal NK/T cell lymphoma nasal type
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      Transformed mycosis fungoides
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      Unknown
    description
    ALK-1=anaplastic lymphoma kinase; ALCL=anaplastic large cell lymphoma
    param Type
    COUNT_OF_PARTICIPANTS
    title
    PTCL Subtype Based on Central Diagnosis
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      131
    units
    Participants
groups
  1. description
    Participants received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Participants who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
    id
    BG000
    title
    Romidepsin
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.83
          value
          59.4
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          42
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          89
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          116
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      Other
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.2348
          value
          1.84
      denoms
      1. counts
        1. group Id
          BG000
          value
          128
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    participants with a Baseline measurement
    title
    Body Surface Area (BSA)
    unit Of Measure
    m^2
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          46
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          66
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      2
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      Missing
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      Unknown
    description
    The ECOG scale is as follows: Grade 0: Fully active, able to carry on all pre-disease activities without restriction; Grade 1: Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; Grade 2: Ambulatory and capable of all self-care but unable to work. Up and about more than 50% of waking hours; Grade 3: Capable of only limited self-care, confined to bed or chair \> 50% of waking hours; Grade 4: Completely disabled. Cannot carry on any self-care. Confined to bed or Chair.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group Performance Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          2.6654
          value
          2.268
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Duration of peripheral T-cell lymphoma (PTCL)
    unit Of Measure
    years
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          69
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      PTCL Unspecified (NOS)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          27
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      Angioimmunoblastic T-cell lymphoma (AITL)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          21
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      ALK-1 negative ALCL
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      Enteropathy-type T-cell lymphoma
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      Subcutaneous panniculitis-like T-cell lymphoma
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      ALK-1 positive ALCL
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      Cutaneous γδ T-cell lymphoma
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      Extranodal NK/T cell lymphoma nasal type
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      Transformed mycosis fungoides
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          131
        units
        Participants
      title
      Unknown
    description
    ALK-1=anaplastic lymphoma kinase; ALCL=anaplastic large cell lymphoma
    param Type
    COUNT_OF_PARTICIPANTS
    title
    PTCL Subtype Based on Central Diagnosis
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice